Olympus Corporation of the Americas: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

Agency Publication Date: July 17, 2023

Affected Products

Product: Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60

All serial numbers BF-XT40** OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 UDI: 04953170055980 BF-P60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 UDI: 04953170339288 BF-MP60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 UDI: 04953170338394 BF-1T60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 UDI: 04953170339264

Product: Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2

All serial numbers BF-PE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2 UDI: 04953170339974 BF-TE2 BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 UDI: 04953170339998

Product: Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150

All serial numbers BF-P150* BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150 UDI: 04953170288876 BF-1T150 BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150 UDI: 04953170288968

Product: Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160

All serial numbers BF-XT160* EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160 UDI: 04953170340147

Product: Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170

All serial numbers BF-Q170 BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 UDI: 04953170342912

Product: Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q180, BF-Q180-AC, BF-1T180, BF-1TQ180

All serial numbers BF-P180* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180 UDI: 04953170339288 BF-Q180** EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 UDI: 04953170339301 BF-Q180-AC* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC UDI: 04953170340086 BF-1T180* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180 UDI: 04953170339325 BF-1TQ180* EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180 UDI: 04953170339349

Product: Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190, BF-XT190, BF-1TH190

All serial numbers BF-H190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190 UDI: 04953170434754 BF-Q190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 UDI: 04953170335198 BF-XT190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT190UDI: 04953170402470 BF-1TH190 EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 UDI: 04953170434778

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92362

Status: Active

Manufacturer: Olympus Corporation of the Americas

Manufactured In: United States

Units Affected: 7 products (1535 units; 4 units; 9 units; 284 units; 1 units; 17,609 units; 9,684 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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